The hypotheses is that image guided hybrid hyper-fractionated dose escalation with mucosal sparing proton therapy is a feasible and safe treatment for Locally Advanced Head and Neck Cancer patients.
ID
Bron
Verkorte titel
Aandoening
Locally Advanced Head and Neck Cancer (HPV-negative)
Ondersteuning
Dr. Mohamed and Fuller received/receives funding and salary support unrelated to this project during the period of study execution from: the NIH National Cancer Institute (NCI) Early Phase Clinical Trials in Imaging and Image-Guided Interventions Program (R01CA218148), the National Institutes of Health (NIH) National Institute for Dental and Craniofacial Research (NIDCR) Establishing Outcome Measures Award (R01DE025248/R56DE025248).
Dr. Fuller received funding unrelated to this project during the period of study execution from NIH/NCI Cancer Center (P30CA016672, P50 CA097007, and R01CA2148250); from NIH/NIBIB (R25EB025787-01); from NIH/NSF (NSF1557679); NSF-CMMI grant (NSF1933369); and the Sabin Family Foundation.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Severe unacceptable local adverse events which are radiotherapeutically attributable. Specifically, CTCAEv5 grade 4 mucositis, dermatitis or aspiration that does not resolve to a grade ≤3 in 3 months, and CTCAEv5 grade≤3 myelopathy, and/or osteonecrosis.
Achtergrond van het onderzoek
This phase I trial studies the toxicities of dose-escalation with image-guided hybrid hyper-fractioned proton therapy in treating patients with (unresectable) locally advanced head and neck cancer. The in dose radiation frequency and additional boosr dose investigated in this study may help to better control the tumor and prevent it from coming back or growing. The goal of this study is to test a new radiation schedule that administers more radiation to the tumor tissue using image guided proton therapy for patients that have a high risk of having a tumor recurrence (the tumor comes back after treatment).
Doel van het onderzoek
The hypotheses is that image guided hybrid hyper-fractionated dose escalation with mucosal sparing proton therapy is a feasible and safe treatment for Locally Advanced Head and Neck Cancer patients.
Onderzoeksopzet
weekly during radiation, and at 6 weeks, 3, 6, 9, 12 months after therapy in the first year, subsequently every 4 months in the second year and then every 9 months
Onderzoeksproduct en/of interventie
Radiation dose escalation with image-guided hybrid hyper-fractionated with proton therapy, while sparing the mucosal and bone structures
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Biopsy proven diagnosis of squamous cell carcinoma of HNC originating in the oropharynx, hypopharynx, larynx, or oral cavity (base of tongue)
• The primary radiotherapy with curative intend, either in combination with chemotherapy or not
• Inoperable locally advanced disease, defined as:
• AJCC 8th stage ≥ III
• T stage ≥2
• Negative for HPV by p16 IHC or ISH
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Previous radiation treatment in the head and neck region
• Head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies
• Pregnant or breast-feeding females
• Patients younger than 18 years
• Patients with ECOG performance score of 2 or lower
• Contraindications to MRI
• Patients that continue to smoke or abuse alcohol during treatment
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
IPD will be shared after trial completion as allowed by national privacy requirements through a planned Data Descriptor publication of anonymized/deidentified data.
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9603 |
| Ander register | IRB MD Anderson Cancer Center : IRB 2019-0467 |